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Acute Myeloblastic LeukemiaCOVLANCT04452604

Multicentric Registry of Patients With Acute Leukemia Infected by COVID-19

An observational study of Acute Myeloblastic Leukemia and Acute Lymphoblastic Leukemia, run by French Innovative Leukemia Organisation at 27 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The COVID-19 epidemic (Coronavirus Disease 2019) currently raging in France is an emerging infectious disease linked to a virus of the genus coronavirus (SARS-CoV-2). Epidemiologically, acute myeloblastic leukemias (AML) are the most common of acute leukemias. Read more about this study

Who is it for?
Ages 18 years and older
How many people
79 participants
Where
27 sitesFrance
Study dates
11 Sep 2020to 7 Jul 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: COVID-19 infected patients with AML or ALL

Who may be able to join

  • Diagnosis of acute leukemia according to WHO criteria 2016 ≤ 5 years
  • Diagnosis of a proven or probable SARS-CoV-2 infection according to the following criteria:
  • Proven infection: positive Polymerase Chain Reaction (PCR) regardless of the radio-clinical picture (other tests made available later and having good diagnostic performance will be accepted)
  • Probable infection: negative PCR but association of
  • Evocative clinical signs, of recent installation: fever, respiratory signs (cough, dyspnea, chest pain), body aches, sore throat, rhinorrhea, headache, diarrhea / abdominal pain, frank asthenia, loss of taste / smell, conjunctivitis, type of frostbite AND
  • evocative radiological signs, on CT: diffuse or diffuse aspect of frosted glass, condensations including pseudo-nodular condensations, association of frosted glass and condensation within the same lesion, nodules and micronodules, thickening of the interlobular septa) or on chest radiography: interstitial, alveolo-interstitial or alveolar syndrome, single or bilateral AND
  • absence of differential diagnosis

Who cannot join

  • None

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

France27 sites

  • Chu Amiens

    Amiens, 80054

  • CHU ANGERS - Maladies du sang

    Angers, 49933

  • Ch Avignon

    Avignon, 84000

  • CH de la Côte Basque - Hématologie

    Bayonne, 64109

  • CHU Caen - IHBN - Hématologie Clinique

    Caen, 14033

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, 91100

  • Centre Hospitalier de Dunkerque

    Dunkirk

  • CHU de Grenoble - Hopital Michallon

    Grenoble, 38043

  • Centre Hospitalier du Mans

    Le Mans, 72000

  • Hôpital Saint Vicent de Paul

    Lille, 59000

  • Chu Limoges

    Limoges

  • Institut Paoli-Calmettes - Hématologie 2

    Marseille, 13000

  • HOPITAL SAINT ELOI - Hematologie

    Montpellier, 34295

  • HOPITAL E. MULLER - Hématologie

    Mulhouse, 68070

  • CHU HOTEL DIEU - Hématologie Clinique

    Nantes, 44093

  • CHU Caremeau

    Nîmes, 30029

  • CENTRE HOSPITALIER SAINTJEAN - Hématologie Clinique

    Perpignan, 66000

  • Bordeaux Pessac

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU Reims - Hôpital Robert Debré - Hématologie Clinique

    Reims, 51100

  • CHU Pontchaillou - Hématologie

    Rennes, 35033

  • Chu de La Reunion - Site Sud

    Saint-Pierre

  • Institut de Cancérologie Lucien Neuwirth

    Saint-Priest-en-Jarez, 42271

  • Institut Universitaire du Cancer de Toulouse Oncopole - Service d'Hématologie

    Toulouse, 31059

  • CHU de Brabois

    Vandœuvre-lès-Nancy, 54500

  • Centre Hospitalier de Versailles

    Versailles

  • Institut Gustave Roussy

    Villejuif

Other trials in France

About this study

Official title: National Retrospective Monitoring of Patients With Acute Leukemia Infected by COronaVirus Disease 2019 (COVID-19)

The COVID-19 epidemic (Coronavirus Disease 2019) currently raging in France is an emerging infectious disease linked to a virus of the genus coronavirus (SARS-CoV-2). Epidemiologically, acute myeloblastic leukemias (AML) are the most common of acute leukemias. The incidence of acute lymphoblastic leukemia (ALL) is 900 new cases in France in 2018, of which 57% in humans. The treatments administered to AML and ALL patients induce variable immunosuppression: neutropenia, neuropathy, deficits in humoral or cellular immunity or combinations of these deficits. Patients with AML or ALL therefore represent a population at high risk of developing a serious form in the event of infection with SARS-CoV-2. To date, no data is available in the literature to assess the impact of the COVID-19 epidemic in the population of patients with acute leukemia.

The main objective of the study is to determine the clinical and biological prognostic factors during SARS-CoV-2 infection in patients with acute leukemia.

Medical subject headings
Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical prognostic factors for infection with COVID-19

    Factors associated with overall survival will be analyzed : center, sex, leukemia subtype, previous treatment by corticosteroids, and comorbidities (respiratory, renal, cardiac, weight, diabetes)

    Measured: Day 0

  2. Biological prognostic factors for infection with COVID-19

    neutrophils and lymphocytes count at the time of SARS-COV2 infection

    Measured: Day 0

  3. Medical care of Coronavirus infection

    Describe the management carried out concerning coronavirus infection and its impact of the treatment of acute leukemia (non-invasive ventilation, orotracheal intubation, vasopressor requiring, treatments used, cause of death

    Measured: within 12 months after diagnosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2020
  2. Study start11 Sep 2020
  3. Primary completion30 Jun 2021
  4. Study completion7 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04452604
Sponsor's protocol ID
COVLA
Acronym
COVLA
Status last verified
Jul 2022
First submitted
18 Jun 2020
Last updated
27 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myeloblastic Leukemia and Acute Lymphoblastic Leukemia, run by French Innovative Leukemia Organisation at 27 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical prognostic factors for infection with COVID-19 (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04452604.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.

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